SB631: SB631 "Veterans Mental Health Innovations Act"; enact

26 LC 46 1527 Senate Bill 631 By: Senators Halpern of the 39th, Anderson of the 43rd, Wicks of the 34th, Jackson of the 41st and Parent of the 44th A BILL TO BE ENTITLED AN ACT To amend Article 1 of Chapter 2A Title 31 of the Official Code of Georgia Annotated,1 relating to general provisions of the Department of Public Heal th, so as to authorize the2 department to award grants to eligible entities to conduct clin ical trials approved by the3 United States Food and Drug Administration as a part of a multi state consortium using4 ibogaine as an investigational new drug for the treatment of opioid use disorder, co-occurring5 substance use disorder, and any other neurological or mental health conditions as related to6 veterans for which ibogaine demonstrates efficacy; to provide f or waiver; to provide for7 definitions; to provide for revenue attributable to intellectua l property rights and other8 commercial rights relative to clinical trials; to provide for t he awarding of grants by the9 Department of Public Health; to provide for certain eligibility requirements; to provide for10 certain verifications; to provide for certain limitations on di sbursement; to provide for11 reporting; to provide for construction; to provide for related matters; to provide for a short12 title; to provide for an effective date; to provide for contingencies; to repeal conflicting laws;13 and for other purposes.14 BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:15 S. B. 631 - 1 - 26 LC 46 1527 SECTION 1.16 This Act shall be known and may be cited as the "Veterans Mental Health Innovations Act." 17 SECTION 2.18 Article 1 of Chapter 2A Title 31 of the Official Code of Georgi a Annotated, relating to19 general provisions of the Department of Public Health, is amend ed by adding a new Code20 section to read as follows:21 "31-2A-21.22 (a) As used in this Code section, the term:23 (1) 'Armed forces' means the United States army, navy, marine corps, space force, coast24 guard, air force, Georgia National Guard, or other reserve unit of the United States25 military.26 (2) 'Clinical trial' means a clinical trial program approved by the federal Food and Drug27 Administration and conducted in this state as part of a multist ate consortium for the28 investigational use of ibogaine for the treatment of opioid use disorder, co-occurring29 substance use disorder, and any other neurological or mental health conditions as related30 to veterans for which ibogaine demonstrates efficacy.31 (3) 'Ibogaine' means ibogaine and ibogaine based therapeutics, including ibogaine32 analogs.33 (4) 'Multistate consortium' means a collection of state, resea rch institutions or state34 agencies from different states collaborating or associating for the purpose of conducting35 clinical trials concerning the medicinal use of ibogaine.36 (5) 'Veteran' means a former member of the armed forces who re ceived an honorable37 discharge.38 (b) Subject to appropriations by the General Assembly for such purpose, the department39 shall be authorized to award grants to entities to participate in clinical trials, provided that40 the department has obtained a waiver or authorization from the federal government if such41 S. B. 631 - 2 - 26 LC 46 1527 department determines that such waiver or authorization is required under federal law for42 the implementation of any provision of this Code section. The department shall only award43 a grant pursuant to this Code section to an applicant that:44 (1) Is located within this state;45 (2) Has a history of proven research and treatment of neurolog ical conditions and46 expertise in substance dependence and emotional, physical or ne urological trauma as47 related to veterans;48 (3) Has a neurosurgery program with clinical and research facilities authorized to enter49 into a multistate consortium agreement and is:50 (A) Staffed by professionals with expertise in neurological an d neurosurgical51 conditions; and52 (B) Capable of providing the necessary infrastructure and expertise to deliver cardiac53 intensive care services;54 (4) Has the ability to facilitate research and innovation in the diagnosis and treatment of55 neurological conditions as related to veterans;56 (5) Has demonstrated to the department that the entity has the financial capability to57 match moneys from gifts, grants, and donations from sources other than this state in the58 amount of at least $7 million to conduct the clinical trials described in this Code section;59 and60 (6) Has agreed to enter into an agreement with a multistate co nsortium by which the61 applicant or an agent or joint venture thereof has agreed to:62 (A) Submit an investigational new drug application to the United States Food and Drug63 Administration in accordance with 21 C.F.R. Part 312; and64 (B) Request a breakthrough ther apy designation for ibogaine fro m the United States65 Food and Drug Administration under 21 U.S.C. Section 356.66 (c) An applicant selected to conduct clinical trials shall quarterly, prepare and submit to the67 department:68 S. B. 631 - 3 - 26 LC 46 1527 (1) A report on the progress of the clinical trials conducted under this Code section; and69 (2) A financial status report, including information verifying expenditures of state funds70 and required matching funds.71 (d) All revenue attributable to all intellectual property rights and other commercial rights72 that may arise from the clinical trials conducted by the entity receiving the grant described73 in subsection (b) of this Code section during the period for which trials are funded shall be74 deposited into the state general fund. For purposes of this subsection, intellectual property75 rights and other commercial rights arising from the clinical tr ials conducted under this76 Code section shall include any of the following as related to such trials:77 (1) Intellectual property, technology, and inventions;78 (2) Patents, trademarks, and licenses;79 (3) Proprietary and confidential information;80 (4) Trade secrets, data, and databases;81 (5) Tools, methods, and processes;82 (6) Treatment models or techniques;83 (7) Administration protocols; and84 (8) Works of authorship.85 (e) The commissioner shall prepare an accounting of the funds expended pursuant to this86 Code section during the most recently completed fiscal year to be reported to the Office of87 Planning and Budget, the House Budget and Research Office, and the Senate Budget and88 Evaluation Office by January 1 of each year.89 (f) The department shall submit to the General Assembly a report on the progress of the90 clinical trials and their related financial status conducted under this Code section not later91 than December 1 of each year. Such report shall include inform ation verifying92 expenditures of state funds and required matching funds.93 (g) Nothing in this Code section shall be construed to preclud e a physician from94 administering ibogaine in accordance with federal law and state law."95 S. B. 631 - 4 - 26 LC 46 1527 SECTION 3.96 (a) This Act shall become effective only if funds are specifically appropriated for purposes97 of this Act in an appropriations Act enacted by the General Assembly.98 (b) If funds are so appropriated, then this Act shall become effective on the later of:99 (1) The date on which such appropriations Act becomes effective; or100 (2) The beginning date of the fiscal year for which such appropriations are made.101 (c) If funds are not appropriated by July 1, 2029, as described in this section, this Act shall102 stand repealed.103 SECTION 4.104 All laws and parts of laws in conflict with this Act are repealed.105 S. B. 631 - 5 -